NCT05201872

Brief Summary

The primary purpose of this study is to compare the differences of bacteriological in rectal cancer patients undergoing laparoscopic or transanal endoscopy radical resection. The secondary purpose is to compare the effects of two different surgical methods on postoperative complications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 20, 2022

Last Update Submit

January 21, 2022

Conditions

Rectum Cancer

Outcome Measures

Primary Outcomes (1)

  • The positive rate of bacterial contamination of peritoneal washings

    Bacterial contamination positive rate determined by bacterial culture of intra-operative peritoneal washings

    1 years

Secondary Outcomes (1)

  • Postoperative complications

    a month

Study Arms (2)

laparoscopic surgery

Different surgical methods for rectal cancer resection

Transanal endoscopic surgery

Different surgical methods for rectal cancer resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

216 rectal cancer patients will be enrolled. Patients must be older than 18 years.

You may qualify if:

  • Primary rectal carcinoma
  • Single lesion
  • No metastasis

You may not qualify if:

  • History of malignant tumors
  • Acute bowel obstruction, bleeding or perforation
  • Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
  • Severe other contradictions of surgery
  • Pregnant women will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Liang Huang

CONTACT

15989101216huangl75@mail.sysu.edu.cn

Mian Chen

CONTACT

13711370070chenmian1997@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 20, 2022

First Posted

January 21, 2022

Study Start

January 15, 2022

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

February 7, 2022

Record last verified: 2022-01

Locations

CN(1)